Identity
- Trade Name
- Fluorinated foam EUDAMED
- Device Name
- Fluoride foam EUDAMED
- Model / Reference
- cantaloupe EUDAMED08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974998831004 EUDAMED
- Basic UDI-DI
- 6974998830802MB EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fluorinated foam by Chengdu I-ReHealth Medical Devices Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6974998830802MB | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chengdu I-ReHealth Medical Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000019445
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED ad3cac44-4361-4148-a36c-36bdab0263b9 61 fields · synced Oct 9, 2026